With some of the recently developed drugs showing unprecedented response rates and consistent improvement in overall survival in some indications, we face the dawn of a new era in anticancer research. New therapeutic targets, novel classes of products, booming and competing pipelines, innovative statistical methods, and a changing regulatory environment are all features of this new era.
More than ever, we need clinical trials that can incorporate the required innovations into their design, conduct, infrastructure and analysis. Fortunately, specialist CROs stand ready to take what they have learned from the past 10 years of oncology drug development and apply it to the new world in which we find ourselves.
These CROs already know how to meet the challenges of segmented study populations and an increasingly competitive development landscape, how to implement complex and adaptive designs, and how to squeeze every ounce of value out of data – skills that pharmaceutical and biotech companies will increasingly require going forward.
Written by Serge Bodart, Chief Commercial Officer, IDDI and Everardo Saad, MD, Medical Director, IDDI. Published in Drug Discovery & Development, July 26, 2021